N.J. Airs PCI Without Onsite Surgery Issue

MONROE TOWNSHIP, N.J. -- It was an impressive gathering in a ballroom off Exit 8A of the New Jersey Turnpike where 200 stakeholders listened to evidence advocating percutaneous coronary intervention (PCI) without surgical backup.

The symposium was organized by the New Jersey Chapter of the American College of Cardiology, in partnership with the New Jersey Department of Health (DoH).

Mary O'Dowd, MPH, New Jersey's health commissioner, noted that the DoH will soon be required to decide whether to amend regulations that bar hospitals without onsite cardiac surgical backup from performing elective PCI.

A large part of the decision will revolve around the results of the CPORT-E trial, which found at 9 months an equivalent rate of major adverse events in centers with or without surgical backup. A number of facilities in New Jersey took part in the study.

But attendee Mark W. Connolly, MD, chairman of surgery at St. Joseph's Regional Medical Center in Paterson, N.J., told MedPage Today that he felt the state had already made its decision and was now just going through the motions.

"The question is not whether elective PCI can be performed safely without surgical backup. It can and the data are clear on that. The main concern should be whether opening the gates to allow anybody to perform the procedure will result in inappropriate patient-care decisions," Connolly said.

"Opening up the possibility of more centers doing elective PCI could squeeze hospitals and physicians to focus on volume, and that is where guidelines could become secondary to financial incentives," he said.

Although Connolly might have a valid concern, it was made clear during the nearly 5-hour meeting here at the Forsgate Country Club that communities would not suddenly be inundated by entrepreneurs just out to make a quick buck.

"The CPORT-E randomized trial showed that elective PCI without surgical backup can be performed safely. What it did not show is that it can be done in every hospital," said panelist Thomas Aversano, MD, of Johns Hopkins Medical Center and the director of the Atlantic C-PORT Projects.

Aversano and others on the panel emphasized the rigorous operating standards required to participate in the CPORT-E trial. All 60 of the participating centers nationwide had to perform more than 200 PCIs per year and operators had to perform at least 75 cases per year (with some differences for more experienced centers). In addition, centers in the trial could not just offer elective PCI; they also had to have capabilities for providing primary PCI all day, all year.

Regulation of Medical Services

Currently in New Jersey, 18 hospitals with traditional, on-site cardiac surgical backup programs are permitted to perform elective PCI. Another 11 hospitals, which do not have on-site backup and were involved in the CPORT-E trial, have been granted conditional permission to continue to perform elective PCI.

To get cath lab services in New Jersey (and 35 other states), one must have a Certificate of Need (CON). The CON program originated in the 1970s and was designed to restrain healthcare costs, said panelist Charles Dennis, MD, of Virtua Health System in Marlton, N.J., and chairman of the Cardiovascular Health Advisory Panel for the New Jersey chapter of the American College of Cardiology (ACC). Dennis' facility took part in the CPORT-E trial.

Dennis outlined the advantages and disadvantages of CONs. Advocates say that CONs are necessary because healthcare is not a typical economic product, or that market forces do not follow the same rules in healthcare, or that they lower healthcare costs and promote appropriate competition.

Those who oppose CONs, he said, insist there is no proof they have lowered healthcare costs. Opponents argue that CONs reduce price competition and may be subject to political influence or institutional needs rather than community needs.

"The bottom line is that this is about developing a quality-driven system of care for patients needing PCI," said panelist Gregory Dehmer, MD, of Texas A&M Health Science Center and a past president of the Society for Cardiovascular Angiography and Interventions (SCAI).

"The quality of a program is not determined solely by the presence or absence of a surgeon. The decision to operate an elective PCI program should be based on the needs of patients and the community," he said.

How States Decide

The way states determine where elective PCI without surgical backup can be performed varies from state to state, Thad Waites, MD, an interventional cardiologist at the Hattiesburg Clinic in Hattiesburg, Miss., and the immediate past chair of the ACC Board of Governors, told MedPage Today during a phone interview.

In Mississippi, for example, the request of a single hospital to perform elective PCI without backup prompted the state Board of Health to organize a committee of local cardiovascular specialists to investigate the matter. The board decided the data supported the request, said Waites, a board member himself.

The board then used scientific statements on PCI from the ACC and SCAI to develop training and competency guidelines for hospitals and operators that fit the needs of Mississippi. The matter then went to public comment and is now approved in the state.

"One of our stipulations is that sites can't just do elective PCI," Waites said. "We specified that they have to be able to do PCI 24 hours a day, 365 days a year."

Ken Kutscher, MD, the governor of the New Jersey chapter of the ACC and moderator of the symposium, said that many states confer with local cardiovascular experts when examining this topic. "Our goal was to do that with national speakers."

The meeting sought to educate O'Dowd and other DoH attendees, as well as cardiologists, hospital administrators, and others, so they would "know how to approach the commissioner with their concerns," Kutscher told MedPage Today.

O'Dowd said she intends to hold other gatherings around the state on the topic.

"This topic is important to us because we're a small hospital. We're looking at whether elective PCI is something we want to do so we can provide cost-effective and timely care," Boriss said.

"The question then becomes whether we provide the volume to meet the needs of the requirements. For us, we have a group of physicians from the University of Pennsylvania who come and do our caths. They have the volume at their facility, but whether that will satisfy the state's requirements is unknown," he said.

"New Jersey is an extremely diverse state, with extreme geographic disparities in care," added Richard P. Falivena, DO, vice president of medical affairs at Cape Regional. "We are looking for the state to apply equity across the entire state so that certain populations, such as ours, do not have geographic barriers put between them and what is the standard of care in the rest of the state."

Both Boriss and Falivena said they will attend other forums on this topic around the state.

What Is Quality?

"Quality is one of those things that is very hard to define, but you know it when you see it," said Dehmer, paraphrasing Robert Pirsig, author of Zen and the Art of Motorcycle Maintenance.

Regarding initiating a PCI program, he said the quality metric has been volume -- the actual number of PCIs being done. The usual quality metrics of mortality or emergency bypass surgery are difficult to use because they happen so infrequently.

He suggested that quality metrics have to be evaluated almost from a local level, particularly involving a robust peer-review program. But along with outcomes, facilities should also examine the appropriateness of the case.

"Safety really doesn't mean anything if several hundred procedures were inappropriate. You have to mix quality with appropriateness," he said.

Ralph Brindis, MD, MPH, of the University of California San Francisco and a past president of the ACC, said there will be many challenges and all of them should be acknowledged:

Is this an issue of free-market competition or should there be state health department and government regulations?

Would the safety and efficacy of PCI at larger hospitals be reduced if their volumes decrease as a result of allowing the procedure to be done at hospitals without onsite cardiac surgical capability?

Would an increase in the number of hospitals doing PCI encourage unnecessary procedures in order to satisfy volume criteria? That's where appropriateness criteria are important, Brindis said.

"Ultimately, however, politics is local and you will have to define what is best for you," Brindis concluded.

He added that cath lab accreditation will help to ensure quality and appropriateness and to remember that it's all about the patient.

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